VOTRIENT TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

L01EX03

INN (International Name):

PAZOPANIB

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Administration route:

ORAL

Units in package:

120

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152743001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-05-27

Summary of Product characteristics

_Votrient (pazopanib hydrochloride) Product Monograph _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR VOTRIENT
®
Pazopanib tablets
Tablets, 200 mg pazopanib (as pazopanib hydrochloride), oral
Antineoplastic Agent
ATC Code: L01XE11
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
July 30, 2015
Date of Revision:
December 30, 2021
Submission Control Number: 255496
_ _
_Votrient (pazopanib hydrochloride) Product Monograph _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
12/2021
7 WARNINGS AND PRECAUTIONS, Combination with other
systemic anti-cancer therapies
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
......................................................................